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Marketing Authorisations Granted in July 2017

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Marketing Authorisations Granted in July 2017 Marketing authorisations granted in July 2017 PL Number Grant Date MA Holder Licensed Name(s) Active Ingredient Quantity Units Legal Status PL 34328/0015 03/07/2017 PANMEDICA ERTAPENEM 1G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ERTAPENEM SODIUM 1046.000 GRAMMES POM PL 46091/0001 03/07/2017 INOPHARM LIMITED SEYLACINE 5 MG FILM COATED TABLET SOLIFENACIN SUCCINATE 5 MILLIGRAMMES POM PL 46091/0002 03/07/2017 INOPHARM LIMITED SEYLACINE 10 MG FILM COATED TABLET SOLIFENACIN SUCCINATE 10 MILLIGRAMMES POM PL 25258/0210 04/07/2017 GLENMARK PHARMACEUTICALS EUROPE LIMITED EMTRICITABINE/TENOFOVIR DISOPROXIL GLENMARK 200 MG/245 MG FILM-COATED TABLETS EMTRICITABINE 200 MILLIGRAMMES POM PL 25258/0210 04/07/2017 GLENMARK PHARMACEUTICALS EUROPE LIMITED EMTRICITABINE/TENOFOVIR DISOPROXIL GLENMARK 200 MG/245 MG FILM-COATED TABLETS TENOFOVIR DISOPROXIL PHOSPHATE 291 MILLIGRAMMES POM PL 00289/2099 05/07/2017 TEVA UK LIMITED BIMATOPROST/TIMOLOL TEVA 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION BIMATOPROST 0.3 MILLIGRAMMES PER MILLILITRE POM PL 00289/2099 05/07/2017 TEVA UK LIMITED BIMATOPROST/TIMOLOL TEVA 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION TIMOLOL MALEATE 6.8 MILLIGRAMMES POM PL 04416/1478 05/07/2017 SANDOZ LIMITED BIMATOPROST/TIMOLOL 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION BIMATOPROST 0.30 MILLIGRAMMES PER MILLILITRE POM PL 04416/1478 05/07/2017 SANDOZ LIMITED BIMATOPROST/TIMOLOL 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION TIMOLOL MALEATE 6.8 MILLIGRAMMES PER MILLILITRE POM PL 04569/1686 05/07/2017 GENERICS (UK) LIMITED BIMATOPROST/TIMOLOL MYLAN 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION BIMATOPROST 0.3 MILLIGRAMMES PER MILLILITRE POM PL 04569/1686 05/07/2017 GENERICS (UK) LIMITED BIMATOPROST/TIMOLOL MYLAN 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION TIMOLOL MALEATE 6.8 MILLIGRAMMES PER MILLILITRE POM PL 44305/0008 06/07/2017 KOANAA HEALTHCARE LIMITED IRINOTECAN HYDROCHLORIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION IRINOTECAN HYDROCHLORIDE TRIHYDRATE 40.00 MILLIGRAMMES POM PL 04569/1684 07/07/2017 GENERICS (UK) LIMITED BIMATOPROST MYLAN 0.1 MG/ML EYE DROPS, SOLUTION BIMATOPROST 0.10 MILLIGRAMMES PER MILLILITRE POM PL 16239/0044 07/07/2017 MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S A ILAXTEN 10MG ORODISPERSIBLE TABLETS BILASTINE 10 MILLIGRAMMES POM PL 16239/0045 07/07/2017 MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S A ILAXTEN 2.5MG/ML ORAL SOLUTION BILASTINE 2.5 MILLIGRAMMES PER MILLILITRE POM PL 21880/0167 07/07/2017 MEDREICH PLC TRAMADOL HYDROCHLORIDE 50 MG CAPSULES TRAMADOL HYDROCHLORIDE 50 MILLIGRAMMES POM PL 25298/0047 07/07/2017 BROWN & BURK UK LIMITED SOLIFENACIN 5 MG FILM-COATED TABLETS SOLIFENACIN SUCCINATE 5 MILLIGRAMMES POM PL 25298/0048 07/07/2017 BROWN & BURK UK LIMITED SOLIFENACIN 10 MG FILM-COATED TABLETS SOLIFENACIN SUCCINATE 10 MILLIGRAMMES POM PL 44041/0037 07/07/2017 NOUMED LIFE SCIENCES LIMITED TRAMADOL HYDROCHLORIDE 50 MG CAPSULES TRAMADOL HYDROCHLORIDE 50 MILLIGRAMMES POM PL 00010/0663 10/07/2017 BAYER PLC NASONEX ALLERGY DEFENCE 0.05% NASAL SPRAY MOMETASONE FUROATE MONOHYDRATE 0.5 MILLIGRAMMES PER GRAM P PL 17907/0614 10/07/2017 BRISTOL LABORATORIES LIMITED IVABRADINE 5 MG FILM-COATED TABLETS IVABRADINE HYDROCHLORIDE 5.39 MILLIGRAMMES POM PL 17907/0615 10/07/2017 BRISTOL LABORATORIES LIMITED IVABRADINE 7.5 MG FILM-COATED TABLETS IVABRADINE HYDROCHLORIDE 8.085 MILLIGRAMMES POM PL 41947/0030 10/07/2017 ELC GROUP SRO DEXAMETHASONE 3.3 MG/ML, SOLUTION FOR INJECTION DEXAMETHASONE SODIUM PHOSPHATE 4.37 MILLIGRAMMES PER MILLILITRE POM PL 46091/0003 10/07/2017 INOPHARM LIMITED GIRAXINE 5 MG FILM-COATED TABLET SOLIFENACIN SUCCINATE 5 MILLIGRAMMES POM PL 46091/0004 10/07/2017 INOPHARM LIMITED GIRAXINE 10 MG FILM-COATED TABLET SOLIFENACIN SUCCINATE 10 MILLIGRAMMES POM PL 00063/0740 11/07/2017 RECKITT BENCKISER HEALTHCARE (UK) LIMITED SCHOLLMED ONCE WEEKLY FUNGAL NAIL TREATMENT 5%W/V MEDICATED NAIL LACQUER AMOROLFINE HYDROCHLORIDE 55.74 MILLIGRAMMES PER MILLILITRE P PL 00289/2104 11/07/2017 TEVA UK LIMITED BORTEZOMIB TEVA 2.5 MG POWDER FOR SOLUTION FOR INJECTION BORTEZOMIB 2.5 MILLIGRAMMES POM PL 14048/0255 11/07/2017 SYNTHON BV ANAGRELIDE 0.5 MG HARD CAPSULES ANAGRELIDE HYDROCHLORIDE MONOHYDRATE 0.61 MILLIGRAMMES POM PL 25258/0226 11/07/2017 GLENMARK PHARMACEUTICALS EUROPE LIMITED LECOMIG 600 MG FILM-COATED TABLETS GABAPENTIN 600.00 MILLIGRAMMES POM PL 25258/0227 11/07/2017 GLENMARK PHARMACEUTICALS EUROPE LIMITED LECOMIG 800 MG FILM-COATED TABLETS GABAPENTIN 800.00 MILLIGRAMMES POM PL 35507/0183 12/07/2017 LUPIN (EUROPE) LIMITED ROSUVASTATIN 10 MG FILM-COATED TABLETS ROSUVASTATIN CALCIUM 10.400 MILLIGRAMMES POM * POM = Prescription only medicine 1 P = Pharmacy only medicine GSL = General Sale List Marketing authorisations granted in July 2017 PL Number Grant Date MA Holder Licensed Name(s) Active Ingredient Quantity Units Legal Status PL 35507/0184 12/07/2017 LUPIN (EUROPE) LIMITED ROSUVASTATIN 20 MG FILM-COATED TABLETS ROSUVASTATIN CALCIUM 20.800 MILLIGRAMMES POM PL 35507/0185 12/07/2017 LUPIN (EUROPE) LIMITED ROSUVASTATIN 40 MG FILM-COATED TABLETS ROSUVASTATIN CALCIUM 41.600 MILLIGRAMMES POM PL 43801/0043 12/07/2017 SCIECURE PHARMA LIMITED LEVETIRACETAM SCIECURE 250 MG FILM-COATED TABLETS LEVETIRACETAM 250 MILLIGRAMMES POM PL 43801/0044 12/07/2017 SCIECURE PHARMA LIMITED LEVETIRACETAM SCIECURE 500 MG FILM-COATED TABLETS LEVETIRACETAM 500 MILLIGRAMMES POM PL 43801/0045 12/07/2017 SCIECURE PHARMA LIMITED LEVETIRACETAM SCIECURE 750 MG FILM-COATED TABLETS LEVETIRACETAM 750 MILLIGRAMMES POM PL 43801/0046 12/07/2017 SCIECURE PHARMA LIMITED LEVETIRACETAM SCIECURE 1000 MG FILM-COATED TABLETS LEVETIRACETAM 1000 MILLIGRAMMES POM PL 20416/0343 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 8MG/12.5MG TABLETS CANDESARTAN CILEXETIL 8.00 MILLIGRAMMES POM PL 20416/0343 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 8MG/12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.50 MILLIGRAMMES POM PL 20416/0344 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 16MG/12.5MG TABLETS CANDESARTAN CILEXETIL 16.00 MILLIGRAMMES POM PL 20416/0344 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 16MG/12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.5 MILLIGRAMMES POM PL 20416/0345 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 32MG/12.5MG TABLETS CANDESARTAN CILEXETIL 32.00 MILLIGRAMMES POM PL 20416/0345 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 32MG/12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.50 MILLIGRAMMES POM PL 20416/0346 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 32MG/25MG TABLETS CANDESARTAN CILEXETIL 32.00 MILLIGRAMMES POM PL 20416/0346 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 32MG/25MG TABLETS HYDROCHLOROTHIAZIDE 25.00 MILLIGRAMMES POM PL 35533/0095 14/07/2017 ASPIRE PHARMA LIMITED MEBEVERINE 200MG MODIFIED RELEASE CAPSULES MEBEVERINE HYDROCHLORIDE 200.00 MILLIGRAMMES POM PL 08553/0594 17/07/2017 DR REDDY'S LABORATORIES (UK) LIMITED NEVIRAPINE DR. REDDY'S 400 MG PROLONGED-RELEASE TABLETS NEVIRAPINE ANHYDROUS 400 MILLIGRAMMES POM PL 28176/0183 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 6.86G PAEDIATRIC POWDER FOR ORAL SOLUTION MACROGOL 3350 6562.50 MILLIGRAMMES POM PL 28176/0183 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 6.86G PAEDIATRIC POWDER FOR ORAL SOLUTION POTASSIUM CHLORIDE 23.300 MILLIGRAMMES POM PL 28176/0183 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 6.86G PAEDIATRIC POWDER FOR ORAL SOLUTION SODIUM CHLORIDE 175.350 MILLIGRAMMES POM PL 28176/0183 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 6.86G PAEDIATRIC POWDER FOR ORAL SOLUTION SODIUM HYDROGEN CARBONATE 89.250 MILLIGRAMMES POM PL 28176/0184 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 13.72G POWDER FOR ORAL SOLUTION MACROGOL 3350 13125.00 MILLIGRAMMES POM PL 28176/0184 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 13.72G POWDER FOR ORAL SOLUTION POTASSIUM CHLORIDE 46.600 MILLIGRAMMES POM PL 28176/0184 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 13.72G POWDER FOR ORAL SOLUTION SODIUM CHLORIDE 350.700 MILLIGRAMMES POM PL 28176/0184 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 13.72G POWDER FOR ORAL SOLUTION SODIUM HYDROGEN CARBONATE 178.500 MILLIGRAMMES POM PL 30322/0021 17/07/2017 ALISSA HEALTHCARE RESEARCH LIMITED VITAMIN D3 800 IU CAPSULES, SOFT COLECALCIFEROL 0.0220 MILLIGRAMMES POM PL 32854/0038 18/07/2017 GALENICUM HEALTH SL TIGECYCLINE 50 MG POWDER FOR SOLUTION FOR INFUSION TIGECYCLINE 50 MILLIGRAMMES PER 5 MILLILITRESPOM PL 08553/0600 19/07/2017 DR REDDY'S LABORATORIES (UK) LIMITED FEBUXOSTAT DR. REDDY'S 80 MG FILM-COATED TABLETS FEBUXOSTAT HEMIHYDRATE 82.28 MILLIGRAMMES POM PL 08553/0601 19/07/2017 DR REDDY'S LABORATORIES (UK) LIMITED FEBUXOSTAT DR. REDDY'S 120 MG FILM-COATED TABLETS FEBUXOSTAT HEMIHYDRATE 123.42 MILLIGRAMMES POM PL 20075/0488 19/07/2017 ACCORD HEALTHCARE LIMITED ATORVASTATIN 10 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 10.34 MILLIGRAMMES POM PL 20075/0489 19/07/2017 ACCORD HEALTHCARE LIMITED ATORVASTATIN 20 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 20.68 MILLIGRAMMES POM PL 20075/0490 19/07/2017 ACCORD HEALTHCARE LIMITED ATORVASTATIN 40 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 41.36 MILLIGRAMMES POM * POM = Prescription only medicine 2 P = Pharmacy only medicine GSL = General Sale List Marketing authorisations granted in July 2017 PL Number Grant Date MA Holder Licensed
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